Substance Use DisordersNCT02654366
Community Supported Risk Reduction for Syringe Exchange Participants
A study testing Risk Reduction Group in people with Substance Use Disorders and Risk Reduction, run by Johns Hopkins University at 1 site in United States.
Trial summary
Efforts to help syringe exchange registrants employ additional HIV risk reduction strategies are often thwarted by strong social networks that reinforce substance use and other risky injection use and sexual behaviors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Substance Use Disorders, Risk Reduction
- What is being tested?
- Risk Reduction Group
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnancy
- Acute medical problem that requires urgent medical management
- Presence of a thought disorder, delusions, hallucinations, or imminent risk of harm to self or others
- Unable to read
- Submission of a drug-positive urine sample
- Pregnancy
Show all 9Show fewer
- Acute medical problem that requires urgent medical management
- Presence of a thought disorder, delusions, hallucinations, or imminent risk of harm to self or others
- Unable to read
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Social Network Intervention for Syringe Exchange Registrants
Efforts to help syringe exchange registrants employ additional HIV risk reduction strategies are often thwarted by strong social networks that reinforce substance use and other risky injection use and sexual behaviors. The proposed study addresses this important problem by evaluating the feasibility and efficacy of a novel Community Supported Risk Reduction group. This structured intervention works with injection drug users and at least one drug-free family or friend to mobilize social support, teach HIV risk reduction skills, develop treatment readiness, and support participation in community activities designed to expand drug-free social networks.
Read the detailed description
Participants of syringe exchange programs routinely suffer from untreated or under-treated substance use disorder, a situation that is associated with significant individual and public health costs. These individuals are also routinely embedded within social networks that reinforce continued drug use and related HIV-risk behaviors. The welfare of these individuals and the public's health can be improved by interventions directed toward reducing drug use risks and expanding drug-free support . Previous work by the investigators has demonstrated that an intervention combining an HIV risk reduction/treatment readiness group with behavioral contingencies is highly associated with increased rates of treatment enrollment and re-engagement, and reduced rates of drug use and HIV-injection risks, for up to one year. This protocol extends this work by adding a new component to the HIV risk reduction/treatment readiness group designed to expand social support and facilitate social network change. This intervention requires syringe exchange registrants to attend the group with a drug-free family or friend from their personal network that can provide stable support and encourage harm reduction and treatment seeking. This intervention uses an alteration network change model and posits that repeated exposure to drug-free community support collaterally reduces exposure to network members that support risk behaviors. This model also provides a pathway to modifying existing social networks by facilitating interaction with the personal social networks of drug-free family and friends. The intervention is supported by research showing that substance users report substantial pockets of drug-free family or friends in their social networks. It is also supported by community reinforcement principles that have shown efficacy in treatment samples, but have not been applied to out-of-treatment drug users. The present study has four primary aims. The first is to characterize natural drug-free support in the social networks of syringe exchangers. The second is to develop a Community Supported Risk Reduction group for syringe exchange participants and their community support. This group teaches skills for HIV risk reduction, treatment seeking, and healthy network expansion. The third and fourth aims are to obtain new data on the feasibility and efficacy of this intervention. Primary outcomes include changes in: 1) perceived social support, and 2) HIV risk behaviors.
- Conditions
- Substance Use Disorders, Risk Reduction
- Being tested
- Risk Reduction Group
- Keywords
- Syringe exchange, HIV risk reduction, Drug-free community support
- Medical subject headings
- Substance-Related Disorders, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Reduction GroupBehavioural
The Risk Reduction and Treatment Readiness skills component includes six modules: 1) BNEP services and substance abuse treatment; 2) nature of chemical dependence (severity/chronicity and medical aspects); 3) infectious diseases (HIV and Hepatitis C virus (HCV) information); 4) injection drug use risk reduction (effective equipment cleaning and drug-splitting techniques); 5) sex risk reduction (reducing high-risk behaviors and effective condom use); and 6) overdose prevention.
The Community Outreach skills component is devoted to discussing the benefits of recovery-focused social support, and directing BNEP registrants and their CSPs to participate in activities together (as determined in the group session) at least 1 time per week to work toward expanding the scope of drug-free social support.
| Study group | Role | What they receive |
|---|---|---|
| Community Supported Risk Reduction Group | Experimental | Six weekly sessions will be scheduled during daytime and evening hours to accommodate the daily schedules of BNEP registrants and their CSPs. Each session meets for 60 minutes. Groups will consist of 5-6 BNEP registrant-CSP dyads (10-12 individuals). While BNEP registrants and CSPs attending the group together will receive an attendance incentive, BNEP registrants attending without a CSP will not earn one. The group leader will follow a manual that includes a structured outline. The group manual content combines risk reduction / treatment readiness and community outreach approaches. Following the introduction, each group session is divided into two components: 1) Risk Reduction and Treatment Readiness (30 min) and 2) Community Outreach skills (20 min). Receives: Behavioral: Risk Reduction Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived social support as assessed by the QRI "support" scale
The investigators anticipate that Baltimore Needle Exchange Program (BNEP) registrants will demonstrate greater levels of perceived social support (QRI "support" scale, a continuous measure) across follow-ups (compared to baseline). Mixed model analyses will be used to evaluate change from baseline to follow-up measures (Months 1, 2, 3). The two remaining QRI subscales ("conflict"; "depth") will also be examined using a similar analytic approach.
Measured: Monthly for 3 months
HIV drug risk behaviors as assessed by the Risk Behavior Survey
The investigators anticipate that BNEP registrants will have lower rates of any drug use risk behaviors (Risk Behavior Survey) across the 3-month evaluation compared to baseline. Drug use risks include any use of a used needle, cooker and cotton for injection or splitting drugs. Generalized Estimating Equations (GEE) will be used to assess change from baseline to follow-up measures (Months 1, 2, 3).
Measured: Monthly for 3 months
HIV sex risk behaviors as assessed by the Risk Behavior Survey
Changes in any sex risk behaviors (Risk Behavior Survey) will be examined using Generalized Estimating Equations (GEE) to assess change from baseline to follow-up measures (Months 1, 2, 3). The investigators expect significant reductions only for the subset of individuals including a romantic partner as a Community Support Person (CSP).
Measured: Monthly for 3 months
Secondary outcomes (2)
Number of participants enrolled in substance abuse treatment
Following each group session, BNEP registrants interested in enrolling in substance abuse treatment will have an opportunity to schedule a referral to a treatment program. Substance abuse treatment enrollment (including treatment name, modality, start date, stop date, days in treatment) will be assessed at months 1, 2, 3 using a series of questions in the Risk Behaviors Survey.
Measured: Monthly for 3 months
Rates of injection drug use
The Drug Use, Injection, and Sexual Risk Behaviors Survey will be administered at months 1, 2, and 3 to assess rates of injection drug use.
Measured: Monthly for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startMay 2016
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Michael Kidorf, Ph.D, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654366
- Sponsor's protocol ID
- IRB00080615
- Other IDs
- 1R34DA040507-01
- Status last verified
- Mar 2020
- First submitted
- 25 Sep 2015
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Network Intervention for Syringe Exchange Registrants
- ClinicalTrials.gov ID
- NCT02654366
- Acronym / sponsor ID
- IRB00080615
- Conditions
- Substance Use Disorders, Risk Reduction
- Keywords
- Syringe exchange, HIV risk reduction, Drug-free community support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efforts to help syringe exchange registrants employ additional HIV risk reduction strategies are often thwarted by strong social networks that reinforce substance use and other risky injection use and sexual behaviors. The proposed study addresses this important problem by evaluating the feasibility and efficacy of a novel Community Supported Risk Reduction group. This structured intervention works with injection drug users and at least one drug-free family or friend to mobilize social support, teach HIV risk reduction skills, develop treatment readiness, and support participation in community activities designed to expand drug-free social networks.
Detailed description
Participants of syringe exchange programs routinely suffer from untreated or under-treated substance use disorder, a situation that is associated with significant individual and public health costs. These individuals are also routinely embedded within social networks that reinforce continued drug use and related HIV-risk behaviors. The welfare of these individuals and the public's health can be improved by interventions directed toward reducing drug use risks and expanding drug-free support . Previous work by the investigators has demonstrated that an intervention combining an HIV risk reduction/treatment readiness group with behavioral contingencies is highly associated with increased rates of treatment enrollment and re-engagement, and reduced rates of drug use and HIV-injection risks, for up to one year. This protocol extends this work by adding a new component to the HIV risk reduction/treatment readiness group designed to expand social support and facilitate social network change. This intervention requires syringe exchange registrants to attend the group with a drug-free family or friend from their personal network that can provide stable support and encourage harm reduction and treatment seeking. This intervention uses an alteration network change model and posits that repeated exposure to drug-free community support collaterally reduces exposure to network members that support risk behaviors. This model also provides a pathway to modifying existing social networks by facilitating interaction with the personal social networks of drug-free family and friends. The intervention is supported by research showing that substance users report substantial pockets of drug-free family or friends in their social networks. It is also supported by community reinforcement principles that have shown efficacy in treatment samples, but have not been applied to out-of-treatment drug users. The present study has four primary aims. The first is to characterize natural drug-free support in the social networks of syringe exchangers. The second is to develop a Community Supported Risk Reduction group for syringe exchange participants and their community support. This group teaches skills for HIV risk reduction, treatment seeking, and healthy network expansion. The third and fourth aims are to obtain new data on the feasibility and efficacy of this intervention. Primary outcomes include changes in: 1) perceived social support, and 2) HIV risk behaviors.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community Supported Risk Reduction Group | Experimental | Behavioral: Risk Reduction GroupSix weekly sessions will be scheduled during daytime and evening hours to accommodate the daily schedules of BNEP registrants and their CSPs. Each session meets for 60 minutes. Groups will consist of 5-6 BNEP registrant-CSP dyads (10-12 individuals). While BNEP registrants and CSPs attending the group together will receive an attendance incentive, BNEP registrants attending without a CSP will not earn one. The group leader will follow a manual that includes a structured outline. The group manual content combines risk reduction / treatment readiness and community outreach approaches. Following the introduction, each group session is divided into two components: 1) Risk Reduction and Treatment Readiness (30 min) and 2) Community Outreach skills (20 min). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Pregnancy
- Acute medical problem that requires urgent medical management
- Presence of a thought disorder, delusions, hallucinations, or imminent risk of harm to self or others
- Unable to read
- Submission of a drug-positive urine sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Reduction GroupThe Risk Reduction and Treatment Readiness skills component includes six modules: 1) BNEP services and substance abuse treatment; 2) nature of chemical dependence (severity/chronicity and medical aspects); 3) infectious diseases (HIV and Hepatitis C virus (HCV) information); 4) injection drug use risk reduction (effective equipment cleaning and drug-splitting techniques); 5) sex risk reduction (reducing high-risk behaviors and effective condom use); and 6) overdose prevention. The Community Outreach skills component is devoted to discussing the benefits of recovery-focused social support, and directing BNEP registrants and their CSPs to participate in activities together (as determined in the group session) at least 1 time per week to work toward expanding the scope of drug-free social support. | Behavioural | Community Supported Risk Reduction Group |
Primary outcome
Perceived social support as assessed by the QRI "support" scale
Time frame: Monthly for 3 months
The investigators anticipate that Baltimore Needle Exchange Program (BNEP) registrants will demonstrate greater levels of perceived social support (QRI "support" scale, a continuous measure) across follow-ups (compared to baseline). Mixed model analyses will be used to evaluate change from baseline to follow-up measures (Months 1, 2, 3). The two remaining QRI subscales ("conflict"; "depth") will also be examined using a similar analytic approach.
HIV drug risk behaviors as assessed by the Risk Behavior Survey
Time frame: Monthly for 3 months
The investigators anticipate that BNEP registrants will have lower rates of any drug use risk behaviors (Risk Behavior Survey) across the 3-month evaluation compared to baseline. Drug use risks include any use of a used needle, cooker and cotton for injection or splitting drugs. Generalized Estimating Equations (GEE) will be used to assess change from baseline to follow-up measures (Months 1, 2, 3).
HIV sex risk behaviors as assessed by the Risk Behavior Survey
Time frame: Monthly for 3 months
Changes in any sex risk behaviors (Risk Behavior Survey) will be examined using Generalized Estimating Equations (GEE) to assess change from baseline to follow-up measures (Months 1, 2, 3). The investigators expect significant reductions only for the subset of individuals including a romantic partner as a Community Support Person (CSP).
2 secondary outcomes
Number of participants enrolled in substance abuse treatment
Time frame: Monthly for 3 months
Rates of injection drug use
Time frame: Monthly for 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kidorf, Ph.D principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Reduction Group in people with Substance Use Disorders and Risk Reduction, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived social support as assessed by the QRI "support" scale (time frame: Monthly for 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.